Australia-based Noxopharm has completed enrolment of patients for Part 2 of the Phase I NOXCOVID trial of Veyonda to inhibit the cytokine release syndrome (CRS) and improve outcomes in hospitalised Covid-19 patients.
Part 2 of the trial is based on the positive data from Part 1, which showed that the 1,800mg dose of the drug was well tolerated by participants with compromised lung function.
Blood samples from trial participants are being assessed at a laboratory in Australia to identify CRS and Covid-19 severity biomarkers.
At the end of the trial, the complete blood biomarkers analysis will be combined with the clinical results, including clinical status and co-morbidities. These data will then be reported to the market.
Veyonda is said to primarily moderate the ceramide/sphingosine-1-phosphate balance and block the Stimulator of Interferon Genes (STING) signalling.
Action on the ceramide/sphingosine-1-phosphate balance is said to cause oncotoxic and immuno-oncology effects, while activity against STING signalling leads to an anti-inflammatory effect.
Noxopharm said in a statement: “Independent pre-clinical studies have confirmed that idronoxil (the active ingredient in Veyonda) blocks this excessive STING response in what appears to be a comprehensive way, raising the prospect of successfully dampening down CRS in at-risk patients, and importantly, potentially blocking the release into the blood of multiple pro-inflammatory factors leading to blood clotting and major organ failure.”
NOXCOVID is being carried out in hospitals across Eastern European countries. The dose-escalation part of the trial included cohorts of 400mg, 600mg, 800mg, 1,200mg and 1,800mg Veyonda daily doses and the dose-expansion phase involved 1,800mg dose.
The objective of the trial is safety and biomarker and clinical responses, Noxopharm noted. It is designed to enrol about 40 Covid-19 patients hospitalised due to respiratory insufficiency.